Lupin bags USFDA approval for Brexpiprazole Tablets

22 Mar 2023 , 09:28 AM

Lupin Limited (Lupin) today announced that the United States Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Application for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, a generic equivalent of Otsuka Pharmaceutical Company Ltd.’s Rexulti Tablets. 

Lupin’s Pithampur facility in India would manufacture this product.

As per IQVIA MAT December 2022 data, Brexpiprazole Tablets (RLD Rexulti), 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, had an estimated annual sales of USD 1,575 million in the United States.

Brexpiprazole tablets are used to treat various mental health conditions such as schizophrenia and major depressive disorder. Brexpiprazole is typically prescribed as part of a comprehensive treatment plan that may also include therapy, lifestyle changes, and other medications.

This medication works by helping to restore the balance of certain natural chemicals in the brain, which can alleviate symptoms such as hallucinations, delusions, and feelings of sadness or hopelessness.

At around 9.20 AM, Lupin was trading at Rs649.65, against the previous close of Rs649.40 on NSE. The counter opened at Rs650.25.

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